Xarelto

"Sept. 8, 2011 -- An FDA advisory panel has voted to recommend approval of a new blood thinner to prevent strokes and dangerous blood clots in patients with the heart rhythm disorder atrial fibrillation.

Switching To And From XARELTO

Switching from Warfarin to XARELTO

When switching patients from warfarin to XARELTO, discontinue
warfarin and start XARELTO as soon as the International Normalized Ratio (INR)
is below 3.0 to avoid periods of inadequate anticoagulation.

Switching from XARELTO to Warfarin

No clinical trial data are available to guide converting
patients from XARELTO to warfarin. XARELTO affects INR, so INR measurements
made during coadministration with warfarin may not be useful for determining
the appropriate dose of warfarin. One approach is to discontinue XARELTO and
begin both a parenteral anticoagulant and warfarin at the time the next dose of
XARELTO would have been taken.

Switching from XARELTO to Anticoagulants other than
Warfarin

For patients currently taking XARELTO and transitioning
to an anticoagulant with rapid onset, discontinue XARELTO and give the first
dose of the other anticoagulant (oral or parenteral) at the time that the next
XARELTO dose would have been taken [seeDRUG INTERACTIONS].

Switching from Anticoagulants other than Warfarin to
XARELTO

For patients currently receiving an anticoagulant other
than warfarin, start XARELTO 0 to 2 hours prior to the next scheduled evening
administration of the drug (e.g., low molecular weight heparin or non-warfarin
oral anticoagulant) and omit administration of the other anticoagulant. For
unfractionated heparin being administered by continuous infusion, stop the
infusion and start XARELTO at the same time.

Nonvalvular Atrial Fibrillation

For patients with creatinine clearance (CrCl) > 50
mL/min, the recommended dose of XARELTO is 20 mg taken orally once daily with
the evening meal. For patients with CrCl 15 to 50 mL/min, the recommended dose
is 15 mg once daily with the evening meal [seeUse in Specific Populations].

Treatment Of Deep Vein Thrombosis (DVT), Pulmonary
Embolism (PE), And Reduction In The Risk Of Recurrence Of DVT And Of PE

The recommended dose of XARELTO for the initial treatment
of acute DVT and/or PE is 15 mg taken orally twice daily with food for the
first 21 days. After this initial treatment period, the recommended dose of
XARELTO is 20 mg taken orally once daily with food, at approximately the same
time each day. The recommended dose of XARELTO for reduction in the risk of
recurrence of DVT or PE is 20 mg taken orally once daily with food at
approximately the same time each day [seeClinical Studies].

The recommended dose of XARELTO is 10 mg taken orally
once daily with or without food. The initial dose should be taken 6 to 10 hours
after surgery provided that hemostasis has been established [see Discontinuation for Surgery and other Interventions].

For patients undergoing hip replacement surgery,
treatment duration of 35 days is recommended.

For patients undergoing knee replacement surgery,
treatment duration of 12 days is recommended.

Discontinuation For Surgery And Other Interventions

If anticoagulation must be discontinued to reduce the
risk of bleeding with surgical or other procedures, XARELTO should be stopped
at least 24 hours before the procedure to reduce the risk of bleeding [see WARNINGS
AND PRECAUTIONS]. In deciding whether a procedure should be delayed until
24 hours after the last dose of XARELTO, the increased risk of bleeding should
be weighed against the urgency of intervention. XARELTO should be restarted
after the surgical or other procedures as soon as adequate hemostasis has been
established, noting that the time to onset of therapeutic effect is short [see
WARNINGS AND PRECAUTIONS]. If oral medication cannot be taken during or
after surgical intervention, consider administering a parenteral anticoagulant.

Missed Dose

If a dose of XARELTO is not taken at the scheduled time,
administer the dose as soon as possible on the same day as follows:

For patients receiving 15 mg twice daily: The patient
should take XARELTO immediately to ensure intake of 30 mg XARELTO per day. In
this particular instance, two 15 mg tablets may be taken at once. The patient
should continue with the regular 15 mg twice daily intake as recommended on the
following day.

For patients receiving 20 mg, 15 mg or 10 mg once daily:
The patient should take the missed XARELTO dose immediately.

Administration Options

For patients who are unable to swallow whole tablets, 10
mg, 15 mg or 20 mg XARELTO tablets may be crushed and mixed with applesauce
immediately prior to use and administered orally. After the administration of a
crushed XARELTO 15 mg or 20 mg tablet, the dose should be immediately followed
by food [see Important Food Effect Information, Nonvalvular Atrial Fibrillation, Treatment of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), and Reduction in the Risk of Recurrence of DVT and of PE and CLINICAL PHARMACOLOGY].

Administration via nasogastric (NG) tube or gastric
feeding tube

After confirming gastric placement of the tube, 10 mg, 15
mg or 20 mg XARELTO tablets may be crushed and suspended in 50 mL of water and
administered via an NG tube or gastric feeding tube. Since rivaroxaban
absorption is dependent on the site of drug release, avoid administration of
XARELTO distal to the stomach which can result in reduced absorption and
thereby, reduced drug exposure. After the administration of a crushed XARELTO
15 mg or 20 mg tablet, the dose should then be immediately followed by enteral
feeding [seeCLINICAL PHARMACOLOGY].

Crushed 10 mg, 15 mg or 20 mg XARELTO tablets are stable
in water and in applesauce for up to 4 hours. An in vitro compatibility study
indicated that there is no adsorption of rivaroxaban from a water suspension of
a crushed XARELTO tablet to PVC or silicone nasogastric (NG) tubing.

HOW SUPPLIED

Dosage Forms And Strengths

10 mg tablets: Round, light red, biconvex and
film-coated with a triangle pointing down above a “10” marked on one side and
“Xa” on the other side

15 mg tablets: Round, red, biconvex, and
film-coated with a triangle pointing down above a “15” marked on one side and
“Xa” on the other side

20 mg tablets: Triangle-shaped, dark red, and
film-coated with a triangle pointing down above a “20” marked on one side and
“Xa” on the other side

Storage And Handling

XARELTO (rivaroxaban) Tablets are available in the strengths and packages listed below:

10 mg tablets are round, light
red, biconvex film-coated tablets marked with a triangle pointing down above a
“10” on one side, and “Xa” on the other side.
The tablets are supplied in the packages listed:

20 mg tablets are triangle-shaped, dark red film-coated
tablets with a triangle pointing down above a “20” marked on one side and “Xa”
on the other side. The tablets are supplied in the packages listed: